Merit Medical Systems, Inc. is recalling 212,078 Monarch Inflation Devices, which are syringes used to inflate balloon catheters and monitor fluid pressure during medical procedures. The recall was initiated because a manufacturing defect caused small holes or breaches in the Tyvek sterile packaging of the devices. Consumers and healthcare facilities should identify affected units by checking the catalog and lot numbers on the packaging, as these products may no longer be sterile.
The holes in the sterile barrier could allow bacteria or other contaminants to enter the device packaging. Using a non-sterile device during an angiographic or balloon angioplasty procedure significantly increases the risk of serious infection or sepsis for the patient.
Quarantine and contact manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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